On August 23, 2021, the U.S. Food and Drug Administration (FDA) announced that it had approved the Pfizer-BioNTech (Pfizer) COVID-19 vaccine. This vaccine will be marketed as Comirnaty and is fully approved to prevent coronavirus disease in people 16 years of age and older.
To some, this is no surprise, as this decision has been expected for some time. Others might be thinking, “wait, wasn’t this vaccine already approved by the FDA?” The technical answer to that is “no.” There are currently three coronavirus vaccines available in the United States:
Until August 23, 2021, none of these had full FDA approval. Instead, they had Emergency Use Authorizations from the FDA.
If these vaccines only had Emergency Use Authorizations, but they were readily available and employers could require their employees to take these vaccines, why does full approval of the Pfizer vaccine matter? Let’s answer the following questions to help understand the significance of the FDA’s approval of the Pfizer coronavirus vaccine.
What Is an Emergency Use Authorization?
As the name implies, an Emergency Use Authorization (EUA) allows medical products to be used without FDA approval if there is a public health emergency. The FDA has the legal authority to issue EUAs under 21 U.S.C. § 360bbb-3 (also known as Section 564 of the Food, Drug, and Cosmetic Act). An EUA is effective until the emergency declaration terminates or the FDA revokes the EUA.
As you might imagine, the process of obtaining an EUA is quicker and easier than getting FDA approval. But the applicant requesting an EUA for a vaccine must still take significant steps to show that the benefits of its vaccine outweigh its risks. This includes completing multiple clinical trials and providing the FDA with data for review.
How Is FDA Approval Different from an EUA?
The biggest difference between “approval” and an EUA is that compared to an EUA, getting approval requires the FDA to review a lot more data. The FDA grants an EUA based on “the best available evidence” at the time of the request. In contrast, the FDA grants approval only after reviewing a significantly larger amount of data.
To put this into perspective in regards to the Pfizer coronavirus vaccine, the FDA only had about two months’ worth of safety monitoring data before issuing the EUA. But before granting full approval to the Pfizer vaccine, the FDA reviewed six months of follow-up data. The FDA also sent inspectors to the manufacturing facilities where the vaccine was being produced to ensure they comply with applicable federal quality standards.
When a medical product receives FDA approval, it has the highest endorsement from the FDA concerning the product’s effectiveness and safety.
Will Other Coronavirus Vaccines Get Approved by the FDA?
Possibly. Moderna submitted an application to the FDA for full approval of its vaccine a few months ago. The FDA’s decision is still pending, but should be released soon. And Johnson & Johnson plans on applying for full approval later this year.
Why Does Full FDA Approval Matter?
If a vaccine has full FDA approval, it becomes easier to implement vaccine mandates. There are a few possible reasons for this.
First, people may feel safer getting a vaccine that’s FDA approved. Survey data support this idea.
In a Kaiser Family Foundation (KFF) survey published in June 2021, 30% of adults who had not received the coronavirus vaccine said that they would be more likely to get the vaccine if it received FDA approval.
In a KFF survey published a few weeks later, unvaccinated individuals were asked why they weren’t vaccinated. 16% had concerns that the vaccine was too new, too unknown or not tested enough. 7% said they wanted to wait and see how things turned out.
This data suggests that the FDA’s approval of the Pfizer vaccine means that some people will become more willing to get vaccinated. However, this increase may not be as significant as employers might hope. That’s because the KFF also reports that about 66% of all adults (vaccinated and unvaccinated) already think the coronavirus vaccines have FDA approval or aren’t sure as to the vaccines’ approval or EUA status.
Second, getting full approval is a more involved process requiring much more clinical information and data analysis. This means that employers can have greater confidence that their employees who get vaccinated won’t get hurt from taking the vaccine and that the vaccine will be effective in preventing the spread and severity of a coronavirus infection. Employers may also be less likely to fear a lawsuit from an employee should the vaccine harm the employee.
Third, it can get around state or local restrictions limiting the implementation of vaccine requirements. For example, in Texas, Governor Abbot has banned vaccines mandates in a variety of settings. But this ban only applies to coronavirus vaccines that have an EUA.
Because the Pfizer vaccine now has full approval, local government employers can get around this restriction as long as their vaccine requirement only applies to the Pfizer vaccine.
Around the time the FDA announced that it had approved the Pfizer coronavirus vaccine, various companies announced their employee vaccination requirements. So it appears full approval makes a difference, at least for employers and their vaccination policies.
Does Full Approval of the Vaccine Make a Difference Legally for Employers?
It shouldn’t. Whether a vaccine has an EUA or is fully approved, the vast majority of employers can still require their employees to get vaccinated (a notable exception being Montana employers). Also, FDA approval shouldn’t make much of a difference as to the applicability of any medical and religious exemptions to a vaccine mandate for the workplace.
The legal precedent for vaccine mandates is well-established. Since 1905, it’s well-settled law that states can enforce vaccination mandates. The Supreme Court in Jacobson v. Massachusetts stated that it was “within the police power of a State to enact a compulsory vaccination law” and that “[t]he liberty secured by the Constitution…does not import an absolute right in each person to be at all times…wholly freed from restraint…”
This case, as well as many others that followed, have created the legal framework that supports vaccine requirements imposed by state governments, whether applied to the general public, students or state employees.
As for private employers, many rights found in the Constitution do not apply to the private employment setting because private employers are not the government. One notable example is workplace free speech rights.
So if a government employer can have a vaccine mandate, it’s almost guaranteed a private employer can too, at least from a constitutional law perspective. However, it’s possible for some employees, like those in a union, to have contractual rights that prohibit employers from punishing employees for not getting vaccinated.
Having a coronavirus vaccine with full FDA approval removes a potential psychological hurdle for those hesitant to get vaccinated. It also likely makes employers more comfortable with imposing a mandatory vaccination policy.